MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LOCKING: CALCANEAL PLATE; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Necrosis (1971); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown plates: locking: calcaneal plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in the (b)(6) as follows: this report is being filed after the review of the following journal article: zeman p.,zeman j.,matejka j.,koudela k., (2008) mid-term results of calcaneal fracture treatment by open reduction and internal fixation using a calcaneal locking compression plate from an extended lateral approach, acta chirurgia orthopaedicae et traumatologiae cechosl volume 75,pages 457-464 (czech republic) this study aims to retrospectively evaluate in our patient cohort the mid-term results of surgical treatment of intra-articular calcaneal fractures consisting of open reduction and internal fixation using a calcaneal lcp (locking compression plate) from an extended lateral approach.In the period from august 2005 to september 2007, a total of 49 patients with 61 calcaneal fractures were treated.Of these patients, open reduction with internal calcaneal lcp fixation (orif-calcaneal lcp) was carried out to treat 46 fractures in 38 patients.The group evaluated in the study were 29 patients (2 females,27 males) with a mean age of 34.2 years (19¿55 years) with 33 intra-articular calcaneal fractures treated with open reduction and internal fixation using a calcaneal lcp (orif - open reduction internal fixation) between august 2005 and march 2007.The primary treatment included filling of the calcaneal for which synthetic bone replacement of resorbable calcium phosphate (chronos) was used 9 times, injectable self-solidifying hydroxyapatite implant was used 2 times (1 time x3 wright, 1 time norian srs), and allograft 1 time.The reduction was done using a calcaneal lcp.Patients were followed up no longer than 6 months.The following complications were reported as follows: 2 wound dehiscence.2 marginal necrosis.2 superficial infection.Of the late postoperative complications, a spontaneous subtalar fusion was recorded in one case.The osteosynthetic material was removed in 8 patients within 12 to 16 months from surgery.The removal was indicated for objective or subjective difficulties of patients.Since there was a persistent significant limitation of the mobility of the subtalar joint in six cases, it was loosened by surgical removal of the always present tough connective tissue.This report is for an unknown synthes calcaneal lcp.This is report 1 of 4 for (b)(4).

• Brand Name: UNK - PLATES: LOCKING: CALCANEAL PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11805683
• MDR Text Key: 257179733
• Report Number: 8030965-2021-03795
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention